New study findings show no benefit of prescription omega-3 fatty acids in prevention of recurrent symptomatic atrial fibrillation in affected patients

Findings from a new study show, compared to placebo, treatment
with high-dose prescription omega-3 fatty acids did not reduce the
recurrence of symptomatic atrial fibrillation (AF) among patients
with symptomatic paroxysmal AF or persistent AF who have no
evidence of substantial structural heart disease. The study was
presented today at the American Heart Association’s
Scientific Sessions and also published online in The Journal of the
American Medical Association.

This was a six-month, multicentre, randomized double-blind,
placebo-controlled, parallel-group trial sponsored and funded by
GlaxoSmithKline. It examined the efficacy and safety of
prescription omega-3 fatty acids (LOVAZA®, omega-3-acid ethyl
esters) for the prevention of recurrent symptomatic atrial
fibrillation.

LOVAZA is a prescription medication made from omega-3 fish oil
indicated as an adjunct to diet, to reduce triglyceride levels in
adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of LOVAZA on cardiovascular mortality and morbidity in
patients with elevated triglycerides has not been determined.
LOVAZA is not indicated for the treatment or prevention of
recurrent symptomatic AF. GSK has full commercial rights for LOVAZA
in the United States.

The study showed no benefit in reducing the recurrence of
symptomatic AF in patient groups treated with high-dose,
prescription omega-3 fatty acids and placebo. In both the
pre-specified original analysis and the analysis of an independent
statistician, the rate of recurrence to AF or flutter was higher in
the LOVAZA arm compared to placebo. The incidence of
treatment-emergent adverse events was similar between the two
treatment groups. Five percent of patients on placebo and 4% of
patients taking prescription omega-3 discontinued the study
medication due to adverse events.

Previous clinical trials of omega-3 fish oils used in AF have
yielded mixed results. The study authors reviewed several factors
which might contribute to the differences between their findings
and those of other studies, such as differences in study
populations, dosing regimens, product formulations or use of
concomitant therapies.

“Based on its size and scientific rigour, this study adds
significantly to the body of knowledge of the role and potential
effects of high-dose prescription omega-3 fatty acids in AF,”
said Dr. Murray Stewart, Clinical Vice President of Cardiovascular
and Metabolic Medicines Development at GSK. “We will continue
to review the data from this study in the context of other AF
studies with LOVAZA and other omega-3 fatty acids; however, in this
patient population there was clearly no benefit from
LOVAZA.”

About Atrial Fibrillation

Atrial fibrillation is the most common type of arrhythmia, a
problem with the rate or rhythm of the heartbeat. This leads to
poor blood flow. AF is characterized by an irregular and often
rapid heart rate. People with AF may or may not feel symptoms,
which include heart palpitations, shortness of breath and weakness.
AF may occur rarely or occasionally, or it may become
persistent.

According to the American Heart Association, AF is a disorder
found in about 2.2 million Americans. AF is related to age and the
risk increases the older people get. Men and women are equally
susceptible to the disease. Other risk factors include heart
disease, high blood pressure, other chronic conditions such as
thyroid disease, drinking alcohol and family history.

GlaxoSmithKline – one of the world’s leading
research-based pharmaceutical and healthcare companies – is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further information
please visit www.gsk.com

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